Pesticides through the EPA-approval process

May 2, 2016 -  By

iS18887098checkmark-approvedThe Environmental Protection Agency (EPA) regulates pesticides through a stringent process. It can take chemical companies many months or years before they’re permitted to sell their products. Here’s how it works.

  1. Chemical company invents new product. (This could be a new active ingredient or new combination of ingredients.)
  2. Test + data. The chemical company is responsible for funding and compiling data regarding residue chemistry, environmental fate, toxicology, reentry protection, spray drift, wildlife and aquatic organisms, plant protection, non-target insects, product performance and product chemistry.
  3. Label drafted. A pesticide’s label is considered a legal document. Accuracy in this step is critical to a product’s acceptance. The label must include directions for use, contents and the appropriate warnings. EPA determines aspects like font size, language style and location of text on the bottle.
  4. Pre-registration meeting. Before submitting an application, the applicant company meets with an EPA rep for guidance to save both parties time and money.
  5. Application submitted. The applicant must include forms describing the requested action; the identity and quantity of all chemicals in the product; data on potential risks to human health and the environment; proof of a reliable manufacturing process; labeling; and evidence of meeting all legal and financial obligations. Fees can be up to $100,000.
  6. Initial screen. An EPA rep reviews the application. If anything is missing, applicants must correct applications within the 21-day initial content review period to complete the screen. Otherwise, it’s rejected and EPA may keep 25 percent of the fee.
  7. Preliminary technical screen. Occurring within 45 days of the application’s submission, the preliminary screen determines if the pesticide registration application, data, proposed labeling and more are accurate and complete as such that a full review could result in the EPA granting approval. Any deficiencies must be corrected within 10 business days of notification or EPA will reject the application.
  8. Initial comment period. EPA shares basic information, like applicant name and active ingredient name, with the public for 30 days and fields comments and concerns.
  9. In-depth review*. Data are peer reviewed by scientific experts. Scientists evaluate human health risks, including level of risk from consumption, handling and exposure for well-being adults, children and immune-suppressed people. They also evaluate environmental risks, such as groundwater contamination, risks to endangered and threatened species and potential for endocrine-disruption effects.
  10. Final 30-day comment period. The EPA publishes risk assessment and proposed decision documents. Then, it accepts public comment and petition, analyzes the comments received, revises its decision, if necessary, and prepares a response-to-comment document.
  11. Notice of issuance. If no changes are needed or if the applicant accepts modifications, a notice of issuance is published in the Federal Register.
  12. Pesticide approved for sale.

*Conditional registration. A pesticide may avoid portions of the process if the EPA determines that the applicant didn’t have sufficient time to generate the required data because not enough time has passed since the data requirement was imposed; the use of the pesticide during this time will not cause any unreasonable adverse effect on the environment; and the use of the pesticide is in the public interest, such as to prevent a disease outbreak. A 2013 Natural Resources Defense Council report found that nearly 65 percent of pesticides are approved this way. Critics call the process a loophole that allows under-analyzed pesticides to be sold.

Source: EPA Spokesperson; EPA Documents
illustration: ©istock.com/VCTStyle

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Dillon Stewart

About the Author:

Dillon Stewart graduated from Ohio University’s E.W. Scripps School of Journalism, earning a Bachelor of Science in Online Journalism with specializations in business and political science. Stewart is a former associate editor of LM.

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